Implants may be placed in the human body for a wide variety of reasons. For example, stents are placed in a number of different anatomical lumens within the body. They may be placed in blood vessels to cover vascular lesions or to provide patency to the vessels. Stents are also placed in biliary ducts to prevent them from kinking or collapsing. Grafts may be used with stents to promote growth of endothelial tissue within those vessels. As another example, vena cava filters can be implanted in the vena cava to catch thrombus sloughed off from other sites within the body and carried to the implantation site via the blood stream.
As still another example, vaso-occlusive devices are used for a wide variety of reasons, including for the treatment of intravascular aneurysms. An aneurysm is a dilation of a blood vessel that poses a risk to health from the potential for rupture, clotting, or dissecting. Rupture of an aneurysm in the brain causes stroke, and rupture of an aneurysm in the abdomen causes shock. Cerebral aneurysms are usually detected in patients as the result of a seizure or hemorrhage and can result in significant morbidity or mortality. Vaso-occlusive devices can be placed within the vasculature of the human body, typically via a catheter, either to block the flow of blood through a vessel making up that portion of the vasculature through the formation of an embolus or to form such an embolus within an aneurysm stemming from the vessel. The embolus seals and fills the aneurysm, thereby preventing the weakened wall of the aneurysm from being exposed to the pulsing blood pressure of the open vascular lumen.
One widely used vaso-occlusive device is a helical wire coil having windings, which may be dimensioned to engage the walls of the vessels. These coils typically take the form of soft and flexible coils having diameters in the range of 10-30 mils. Multiple coils will typically be deployed within a single aneurysm. There are a variety of ways of discharging vaso-occlusive coils into the human vasculature. In addition to a variety of manners of mechanically deploying vaso-occlusive coils into the vasculature of a patient, U.S. Pat. No. 5,122,136, issued to Guglielmi et al., describes an electrolytically detachable vaso-occlusive coil that can be introduced through a microcatheter and deployed at a selected location in the vasculature of a patient.
This vaso-occlusive coil is attached (e.g., via welding) to the distal end of an electrically conductive pusher wire. With the exception of a sacrificial joint just proximal to the attached embolic device, the outer surface of the pusher wire is coated with an ionically non-conductive material. Thus, the sacrificial joint will be exposed to bodily fluids when deployed within the patient. A power supply is used to provide power to the core wire, with a conductive patch or intravenous needle located on or in the patient providing a ground return path. Applying a positive voltage to the pusher wire via the power supply relative to the ground return causes an electrochemical reaction between the sacrificial joint and the surrounding bodily fluid (e.g., blood). As a result, the sacrificial joint will dissolve, thereby detaching the vaso-occlusive coil from the pusher wire at the selected site.
While the use of electrolytically detachable vaso-occlusive coils has generally been successful, the period of time needed to detach the vaso-occlusive coils from the pusher wire is relatively long (currently, averaging from 30 to 40 seconds) and variable, resulting in an increase in procedure time. This problem is compounded by the need to deploy multiple vaso-occlusive coils within the patient. The relatively long and varying detachment time is due, in large part, to the relatively large and widely varying tissue impedance between the sacrificial joint and the ground electrode amongst patients. In addition, the bodily fluid surrounding the sacrificial joint may not be the optimum electrolyte (compared with saline) for inducing an electrochemical reaction in the detachment zone, thereby increasing the detachment time. Blood environment may also introduce variability in detachment time due to the possibility of blood clotting and the variations in blood constituents amongst patients.
Theoretically, the voltage of the electrical energy supplied to the sacrificial joint can be increased in order to reduce the detachment time. However, an increased voltage may cause bubbling resulting from gas generation byproducts during the electrochemical reaction, which may insulate the detachment zone adjacent the sacrificial joint from the electrolyte, thereby slowing or stopping the electrochemical reaction, and at the least, causing variability in detachment time. In addition, because gas bubbles are more likely to be contained within the sheath of the microcatheter used to deliver the vaso-occlusive coil, delivery systems are often designed, such that the sacrificial joint extends a certain distance (e.g., 1 mm) from the distal tip of the microcatheter to accommodate dimensional tolerance stackup in the pusher wire and the microcatheter.
Exiting the microcatheter this far, however, degrades kickback performance (i.e., reaction of the microcatheter in response to detachment of the vaso-occlusive coil is to be minimized) due to the stiffness of the distal end of the pusher wire relative to the stiffness of the vaso-occlusive coil. In addition, locating the sacrificial joint this far from the distal tip of the microcatheter may cause it to come into contact with previously deployed vaso-occlusive coils, thereby shorting the sacrificial joint through the coils, resulting in an increase and/or variation in the detachment time. Notwithstanding the bubbling issue, it may sometimes be difficult to ascertain that the sacrificial joint is in contact with the blood, which must occur to initiate the electrochemical reaction and subsequent detachment of the vaso-occlusive coil.